BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CARDIOPULMONARY SUPPORT (CPS) SYSTEM

    K Number: K892664 · Decision Feb 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    3
    Review Days
    306

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    Basic Information

    Device Name
    CARDIOPULMONARY SUPPORT (CPS) SYSTEM
    K Number
    K892664
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bard Cardiosurgery Div
    Date Received
    April 13, 1989
    Decision Date
    February 13, 1990
    Product Code
    DTZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by Bard Cardiosurgery Div

    K Number Device Name
    K913915 BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV
    K892641 BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES